FDA Medical Device Recalls (openFDA)
MAQUET Inc.: Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
- Recall number
- Z-0379-2007
- Recalling firm
- MAQUET Inc.
- Product
- Ventilator System Servo-i V3.1 Maquet Critical Care PC1771
- Status
- Terminated
- Initiated
- 2006-05-23
- Posted
- 2007-02-10
- Terminated
- 2009-03-23
- Reason
- The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator
- Root cause
- Other
- Action
- Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going
- Quantity
- 2,436 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Article number 64-87-800---Serial Numbers 14000-22772
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3008355164
- Firm city
- Bridgewater
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28